WO2000012165A1

WO2000012165A1 - Coupling and stabilization system for proximal end of catheter

Info

Publication number: WO2000012165A1
Application number: PCT/US1999/019827
Authority: WO
Inventors: Kenneth A. Eliasen; Kelly B. Powers
Original assignee: C. R. Bard, Inc.
Priority date: 1998-08-28
Filing date: 1999-08-27
Publication date: 2000-03-09
Also published as: US6332874B1; CA2341529A1

Abstract

A conduit (10) of relatively tough biocompatible material enclosing a longitudinally extending fluid flow lumen (90) has a proximal end configured as a catheter coupling hub (26). The conduit (10) is encircled at the distal end (46) of the catheter coupling hub (26) by a stabilization sleeve (16) made of a contrastingly resilient, soft material suitable for skin contact applications. A pair of stabilization wings (34) extend laterally from the stabilization sleeve (16) at an attachment location (60) separated by a strain relief region (66) from the portion of the stabilization sleeve (16) in which the catheter coupling hub (26) is received. The stabilization sleeve (16) is attached to the conduit (10) at the coupling hub (26) only. The portion of the conduit (10) distal of and adjacent to the catheter coupling hub (26) extends slidably through the stabilization sleeve (16), affording strain relief to the conduit (10).

Description

COUPLING AND STABILIZATION SYSTEM FOR PROXIMAL END OF CATHETER

BACKGROUND

The Field of the Invention

This invention pertains to implantable catheters and, more particularly, to systems for effecting the stabilization on the skin of a patient of the extracorporeal portion of an implanted vascular access catheter.

Background Art

It is now common to use an implanted catheter to repeatedly access the vascular system of a patient and with the catheter perform repeated therapeutic medical activity

Such therapeutic activity could include the intermittent or continuous infusion of medication and fluids, the periodic sampling of blood, or the continuous withdrawal and return of blood for processing outside of the body of the patient The catheters used in these activities are referred to as vascular access catheters.

Before any therapeutic activity can actually commence, however, the vascular access catheter must e implanted in the body of the patient with the distal tip of the catheter residing at the location in the vascular system at which an intended therapeutic activity is appropriate Typically, most of the length of an implanted vascular access catheter resides within blood vessels of the vascular system, extending from the distal tip of the catheter tu a location in the vascular system at which the catheter, by traversing a puncture or incision formed through a wall of the blood vessel in which the catheter is disposed, enters into the surrounding subcutaneous tissue of the patient The location at which this occurs is referred to as a venipuncture site Venipuncture sites are classified on the basis of the position of a venipuncture site in relation to the center of the body of the patient Centra! venipuncture sites are those at the superior or inferior vena cava Midclavicuia; venipuncture sites are located medial of the shoulder of the patient, but latei al of tne subclavian vein Midline venipuncture sites enter the upper basilic or cephalic veins The freedom to select among venipuncture sites is most curtailed relative to patients of slight stature, particular^ small children and infants

Proximal of the venipuncture site, the implanted catheter extends through the subcutaneous tissue of the patient to emerge through the skin at a location that is referred to as the skin exit site Most skin exit sites are chosen as being locations at which the proximal end of the implanted catheter can be easily manipulated by medical personnel Favored among such locations are the neck, the region about the collar bone, the upper leg, the upper arm, and the forearm. Occasionally, the skin exit site is somewhat removed from the venipuncture site.

Then a significant portion of the length of the implanted catheter must be embedded in the subcutaneous tissue of the patient in a surgically created tunnel that extends from the venipuncture site to the skin exit site. The disposition of a significant portion of the length of an implanted catheter in such a subcutaneous tunnel assists in stabilizing the implanted catheter by resisting sliding movement of the catheter back and forth, internally at the venipuncture site or externally at the skin exit site.

On the other hand, with patients of slight stature and particularly with small children and infants, the skin exit site is frequently located immediately adjacent to the venipuncture site. Under such conditions, the portion of the implanted catheter disposed in subcutaneous tissue is so short as to permit the body of the catheter to slide back and forth across the venipuncture site, as well as in and out of the skin exit site

The portion of an implanted catheter that resides in a blood vessel of the vasculai access system or within subcutaneous tissue is referred to as the implanted portion of that catheter. In all instances, a portion of the proximal end of an implanted catheter must remain outside of the body of the patient. It is this portion of an implanted catheter, from the proximal end thereof to the skin access site, that is referred to as the extracorporeal portion of the implanted catheter.

The extracorporeal portion of an implanted catheter must be capable of being selectively coupled to and uncoupled from the tubing and medical equipment outside the body of the patient that are required for therapeutic activity Accordingly, the proximal end of virtually all vascular access catheters terminates in a catheter coupling hub that can be secured in fluid communication with such tubing and medical equipment, or can be capp d. valved, or clamped closed between periods of actual use.

The repeated manipulation of the extracorporeal portion of an implanted cathetei causes wear in the material of the catheter and reduces the reliability of the attachment between the proximal end of the catheter and the catheter coupling hub In the absence of countermeasures, forces imposed on the extracorporeal portion of an implanted catheter result in motions of the extracorporeal portion of the catheter that cause damage to the catheter Motion of the extracorporeal portion of an implanted catheter is also communicated to the skin access site, causing various complications depending upon the length of any subcutaneous tunnel in which a portion of the catheter is imbedded Where such a subcutaneous tunnel is lengthy, motions of the extracorporeal portion of a catheter are relayed directly to the tissue along the subcutaneous tunnel, causing pain and irritation, precluding healing, and leading to infection These results in turn can necessitate the explantation of the catheter Where the portion of an implanted catheter extending subcutaneously between the venipuncture site and the skin exit site is short, motions of the extracorporeal portion of the catheter tend to slide the catheter in and out of the vascular system, causing bleeding and likewise leading to infection

To counteract these undesirable consequences, a variety of measures are undertaken to stabilize th^<? extracorporeal portion of an implanted catheter on the skin of the patient Tie-down materials, such as bandaging, patches with upstanding anchoring posts, medical adhesive tape, belts, elastic bands, and sutures, are used for this purpose

To enhance the effectiveness of such tie-down materials, otherwise unnecessary structures are formed on or attached to the catheter coupling hub or the portion of the proximal end of the catheter attached thereto For example, it is common in the art of catheter implantation to provide one or more flap-like structures that extend laterallv from the catheter coupling hub, from the portion of the proximal end of the catheter attached thereto, or from a tubular sleeve that is disposed about either or both of the catheter and the catheter coupling hub These structures are referred to as stabilization wings

Even without the assistance of any tie-down materials, a stabilization wing prevent^ a catheter coupling hub from rolling along the skin of the patient, pivoting about the skin exit site, and twisting the extracorporeal portion of the catheter between the skin exit site and the coupling hub Sliding motions of a coupling hub on the skin of the patient in directions normal to the length of the catheter are curtailed by the use of tie-down materials applied over or about the coupling hub and against the skin Tie-down materials also prevent movement of the coupling hub and associated catheter in directions aligned with the length of the catheter, motions that could dislodge the catheter from the skin exit site entirely Stabilization wings enhance the purchase afforded on the catheter coupling hub by tie-down materials A system for coupling an implanted catheter to extracorporeal medical equipment and simultaneously stabilizing the extracorporeal portion of that catheter is complex t design. It is a process that must accommodate a variety of functional needs in an environment involving materials as different as human tissue, bodily fluids, flexible fluid conduits, rigid coupling structures, and various tie-down materials. The extracorporeal portion of an implanted catheter functions as an interface between the environment within the body of the patient at the distal tip of the catheter and extracorporeal medical equipment. At this interface, the patency of tubing, the minimizing of wear, the suppression of exit site infection, the freedom of access by medical personnel, and the inconspicuousness of the extracorporeal portion of the implanted catheter are each desired to be maintained to optimum degrees.

As new classes of materials are developed that are suitable for medical use. the potential of each in relation to existing catheter coupling and stabilization systems is investigated, and the design of such systems evolves accordingly Nonetheless, a significant problem in the design of coupling and stabilization systems arises from the contradictory material properties considered desirable among the various components of such systems.

The criteria of suitability for the implanted portion of a catheter that is disposed i the vascular system or the subcutaneous tissue of a patient are dramatically different from the criteria of suitability for the environment outside the body in which the extracorporeal portion of an implanted catheter is disposed and utilized The implanted portion of a vascular access catheter must be so flexible and soft as to avoid damaging internal tissues and to minimize injury to the cells of the blood The extracorporeal portion of that same implanted catheter must, by contrast, sustain repeated manipulation and predictable accidental or intentional abuse

Among the extracorporeal portion of an implantable catheter assembly are components that are hard and entirely inflexible, such as clamps and coupling fixtures that must interact with extracorporeal tubing and medical equipment In view of the possibility of extended contact by the extracorporeal portion of an implanted catheter with the s ^;n of the patient, contrasting material properties of softness and flexibility suitable tor skin contacting applications are also desirable in the extracorporeal interface Thus, many desirable material properties are inconsistent with others As a result, efforts to optimize coupling and stabilization system designs have on occasion used differing classes of materials in various distinct components of the catheter coupling and stabilization system The tension between the mechanical properties required in the extracorporeal interface for an implanted catheter and the patient comfort properties desirable therein has been resolved only to varying degrees in different systems.

One approach to achieving a marriage of the inconsistent material properties desired in a coupling and stabilization system has been to resort to nonunitary coupling and stabilization systems. Such systems involve some components that embody one set of desired material properties that are assembled in the field by medical personnel with other components that embody a contrasting set of desired material properties. For example, brackets optimizing patient comfort properties are secured to the skin of a patient and used as retainers to stabilize catheter coupling hubs made of tough materials possessed of optimized mechanical properties Coupling and stabilization systems configured from components assembled in the field are disadvantaged. however Individual components can become lost, mismatched components can inadvertently be used together, or important components may never be employed as a result of slipshod practices Individual components are small and difficult to manipulate, while the maintenance of inventories of a variety of individual interconnecting coupling and stabilization system elements increases institutional overhead

The selection of structural elements for the extracorporeal interface and the relativc positioning of the selected structural elements in a given coupling and stabilization system similarly require design trade-offs that are unlikely to be optimized in any single system

For example, coupling and stabilization systems that utilize stabilization wings positioned at or adjacent to the catheter coupling hub of the system are effective in precluding movement of the catheter coupling hub This high level of stability in the catheter coupling hub is obtained, however, at the cost of restricting the ease with which the catheter coupling hub can be manipulated by medical personnel. When stabilization wings in an extracorporeal interface are positioned longitudinally at or close to a catheter coupling hub. the stabilization wings and the catheter coupling hub share relatively similar degrees of freedom As a consequence, the coupling and uncoupling of extracorporeal tubing and medical devices at the catheter coupling hub are undesirably difficult Forces imposed on the catheter coupling hub or on the portion of the proximal end of the catheter attached thereto, and motions imparted to either as a result, are communicated directly to the stabilization wings, tending to dislodge the stabilization wings from the skin of the patient. This can be uncomfortable and may lead to tissue irritation at that location Dislodgment of stabilization- wings or a coupling hub from associated tie-down materials or from the skin is likely to lead to catheter damage or catheter explantation.

The positioning of stabilization wings along the proximal end of a catheter distally from the catheter coupling hub produces a different mix of consequences

Stabilization wings have been longitudinally fixed on the exterior of the extracorporeal portion of a catheter tube at a distance from the catheter coupling hub When secured to the skin of a patient, the stabilization wings of such systems permit eas\ access to and use of the catheter coupling hub, because of the flexibility embodied in the material of the catheter between the stabilization wings and the catheter coupling hub Nonetheless, tortional and axial forces imposed on the catheter coupling hub are still communicated directly to the stabilization wings, as surely as if those stabilization wings were positioned immediately at the catheter coupling hub

In some coupling and stabilization systems, stabilization wings are attached to the distal end of an elongated sleeve that is in turn secured at the proximal end thereof tυ the exterior of the catheter coupling hub The full length of the interior of the sleeve is bonded to the exterior of the catheter tube distal of and adjacent to the coupling hub, producing a composite structure distal of the coupling hub Such sleeves thicken, and therefore strengthen, the portion of the catheter tube enclosed therein, increasing the durability of the composite structure Nonetheless, the composite structure tends to exhibit reduced flexibility, impairing intended movements of the catheter coupling hub relative to the stabilization wings Also, axial forces imposed on the catheter coupling hub are communicated directly to the stabilization wings

Some of these difficulties may be overcome, but not without foregoing other advantages.

Stabilization wings are. on occasion, carried on a sleeve that can be slid along the extracorporeal portion of an implanted catheter and positioned on the skin of the patient at any desired distance from the catheter coupling hub The securement of such stabilization wings to the skin prevents lateral movement of the portion of the catheter that is between

- b the stabilization wings and the skin exit site. As the sleeve carrying the stabilization wings is not secured in any fixed relation to the catheter or the coupling hub, undesirable longitudinal and rotational movement of the catheter coupling hub relative to the stabilization wings is nonetheless common. Stabilization wings carried on slidable sleeves are susceptible to disposition at improper locations and are thus sensitive to, and in some cases limited in utility by, the skill and talent of specific medical personnel. Slidable sleeves may be overlooked and never used. Some are simply severed from the catheter assembly out of a misplaced desire to simplify the extracorporeal portion of the implanted structure Longitudinally positionable sleeves carrying stabilization wings are known that completely succumb to this impulse by being manufactured with an axial slit through the sleeve The sleeve may then be detached at will from the system of which it is supposed to be a component.

It may be realistic in addressing the diverse demands placed on the extracorporeal interface of an implanted catheter to acknowledge that any distinct coupling and stabilization system is advantageous in selected respects and disadvantaged in others.

SUMMARY OF THE INVENTION

Accordingly, one broad objective of the present invention is to facilitate the delivery of medical care by improving the capacity of medical personnel to perform repeated therapeutic medical activity in the vascular system of a patient.

Correspondingly, another objective of the present invention is to simultaneously improve the mechanical reliability and the patient comfort provided by the extracorporeal portion of an implanted vascular catheter

In this regard, it is an objective of the present invention to provide a catheter coupling and stabilization system that is not sensitive to or limited by the skill and talent of medical personnel, but rather is a failsafe system.

An additional object of the present invention is to optimize tradeoffs in a catheter coupling and stabilization system between the advantages of material toughness and the desirability of ergonomic compatibility It is a':ι an object of the present invention to provide such a system from which it is not possible to lose, misplace, or misposition constituent components Yet another objective of the present invention is a catheter coupling and stabilization system as described above that is able to reduce skin irritation and infection at the skin exit site, while yet permitting easy manipulation of the catheter coupling hub of the system by medical personnel. It is a further object, of the present invention to provide a catheter coupling and stabilization system in which forces imposed to a catheter coupling hub and the resulting motions imparted thereto avoid being transmitted directly to structures of the system that are used to secure the extracorporeal portion of the implanted catheter to the skin of a patient. Another object of the present invention is to reduce the likelihood of bleeding or infection at the skin exit site for an implanted vascular access catheter, thereby to prolong the potential duration of the catheter in an implanted condition

It is yet another object of the present invention that a catheter coupling system as described above readily communicate to users of the system the size of the catheter with which the system is employed.

Additional objects and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention The objects and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims.

To achieve the foregoing objects, and in accordance with the invention as embodied and broadly described herein, an implantable vascular access catheter is provided th_. includes a conduit of relatively tough biocompatible material and an elastomeric sleeve suitable for skin contact applications that encircles some part of the extracorporeal portion of the implanted conduit. Typically, the distal end of the conduit is configured as a catheter coupling hub by which to effect mechanical and fluid interactions with extracorporeal medical equipment. A pair of stabilization wings extends laterally from opposite sides ot the sleeve at an attachment location that is separated from the catheter coupling hub

As a result of this spatial separation, and in view of the elastomeric composition of the sleeve, a strain relief region results in the sleeve between the stabilization wings and the location of the catheter coupling hub in the sleeve Therefore, according to one aspect of the present invention, a catheter as described above includes resilient means for reducing motion imparted to the skin of the patient by the stabilization wings due to motion imparted to the catheter coupling hub. According to teachings of the present invention, structures performing this function are optimally located between the attachment location on the sleeve for the stabilization wings and the catheter coupling hub that is encircled at least in part by the sleeve.

In accordance with yet another aspect of the present invention, a stabilization sleeve as described above includes an elongated tube having a proximal end, a distal end, and a passageway extending longitudinally between the proximal end and the distal end. The passageway is sized to slideably receive the catheter that is to be used with the stabilization sleeve. A catheter coupling hub receiving socket is included at the proximal end of the tube, and at least the distal end of the catheter coupling hub or the catheter assembly intended to be used with the stabilization sleeve is secured in the receiving socket. The portion of the catheter distal of and adjacent to the catheter coupling hub extends freely through the remainder of the passageway through the stabilization sleeve.

While numerous materials are likely to prove adequate as constituent materials of each respective portion of the coupling and stabilization system, various types of tough polyurethane have been found to be effective for the conduit of the system, while medical grade silicone is the material of choice for the stabilization sleeve.

BRIEF DESCRIPTION OF THE DRAWINGS In order that the manner in which the above-recited and other advantages and objects of the invention are obtained, a more particular description of the invention briefl described above will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered limiting of the scope thereof, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

Figure 1 is a perspective view of the extracorporeal portion of an implanted vascular access catheter having a coupling and stabilization system that incorporates teachings of the present invention and that is connected thereby to extracorporeal medical tubing; Figure 2 is an enlarged perspective view of the extracorporeal portion of the implanted catheter of Figure 1 with the extracorporeal medical tubing shown in Figure 1 disconnected therefrom to display the coupling and stabilization system of the implanted catheter in the assembled state thereof; Figure 3 is an enlarged, partially disassembled perspective view of the catheter assembly and a first embodiment of a stabilization sleeve of the coupling and stabilization system of Figure 2;

Figure 4 is a plan view in cross section of the stabilization sleeve of Figure 3 taken along section line 4-4 shown therein; Figure 5 is an elevation view in cross section of the stabilization sleeve of Figure 3 taken along section line 5-5 shown therein;

Figure 6 is a plan view in cross section of the assembled state of the coupling and stabilization system shown in Figure 2 taken along section line 6-6 therein;

Figure 7 is an elevation view in cross section of the assembled state of the coupling and stabilization system shown in Figure 2 taken along section line 7-7 therein,

Figure 8 is a transverse elevation view in cross section of the assembled state of the stabilization system shown in Figure 2 taken along section line 8-8 therein;

Figure 9 A is an enlarged detail of a portion of the coupling and stabilization system shown in Figure 6; Figure 9B is an illustration of the interaction of the strain relief features of the coupling and stabilization system of Figure 9 A with the portion of the catheter enclosed therein under conditions of strain in which the portion of the system in the right of the figure is displaced in a downward direction;

Figure 9C is an illustration of the interaction of the strain relief features of the system of Figure 9 A with the portion of the catheter enclosed therein under conditions of strain in which the portion of the system in the right of the figure is displaced to the right;

Figure 10A is a plan view schematic illustration of an initial step in the securemen of the extracorporeal portion of a catheter to the skin of a patient using medical adhesive tape and the coupling and stabilization system of Figure 2; Figure 10B is a plan view schematic illustration of a second step in the securemenr of the extracorporeal portion of the catheter of Figure 10A to the skin of a patient; Figure IOC is a plan view schematic illustration of a third step in the securement of the extracorporeal portion of the catheter of Figure 10B to the skin of a patient;

Figure 10D is a plan view schematic illustration of a final step in the securement of the extracorporeal portion of the catheter of Figure 1 to the skin of a patient; Figure 1 1 A is an enlarged detail of a portion of the coupling and stabilization system shown in Figure 7;

Figure 1 IB is an illustration of the interaction of the strain relief features of the system of Figure 1 1 A with the portion of the catheter enclosed therein under conditions of strain in which the portion of the system in the right of the figure is displaced in a downward direction;

Figure 1 1C is an illustration of the interaction of the strain relief features of the system of Figure 1 1 A with the portion of the catheter enclosed therein under conditions of strain in which the portion of the system in the right of the figure is displaced to the right;

Figure 12A is a plan view of a second embodiment of a stabilization sleeve of the type illustrated in Figure 3;

Figure 12B is a plan view of a third embodiment of a stabilization sleeve of the type illustrated in Figure 3 ;

Figure 12C is a plan view of a fourth embodiment of a stabilization sleeve of the type illustrated in Figure 3; and Figure 12D is a plan view of a fifth embodiment of a stabilization sleeve of the type illustrated in Figure 3.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Figure 1 illustrates in perspective view the extracorporeal portion of a vasculai access catheter 10 implanted in the body of a patient at a skin exit site 12 located on the forearm 14. The portion of vascular access catheter 10 illustrated in Figure 1 utilizes a coupling and stabilization system 16 that incorporates teachings of the present invention and that is connected thereby to extracorporeal medical tubing 18. Coupling and stabilization system 16 is shown by way of example in Figure 1 as being secured to the skin 20 of forearm 14 by suture ties 22, although coupling and stabilization system 16 is configured for ready stabilization on the skin of a patient using a plurality of other types of tie-down materials, such as bandaging, patches with upstanding anchoring posts, medical adhesive tape, belts, and elastic bands.

Specific additional features of coupling and stabilization system 16 are illustrated in Figure 2, wherein extracorporeal tubing 18 has been disconnected from coupling and stabilization system 16, revealing male Luer connector threads 24 at the end of coupling and stabilization system 16 opposite skin exit site 12 and the portion of vascular access catheter 10 visible in Figure 2. The internal nature of the components of coupling and stabilization system 16 are not immediately apparent from Figure 2, but such internal structures will be illustrated and discussed subsequently. It will suffice in relation to Figure 2 to present an overview of selected features of coupling and stabilization system 16 that can be appreciated through external inspection.

Luer connector threads 24 are formed on a catheter coupling hub 26 that encloses the proximal terminus of a longitudinally extending fluid flow lumen. The distal end of catheter coupling hub 26, while not visible in the assembled state of coupling and stabilization system 16 illustrated in Figure 2, is secured in an enlarged hub receiving socket 30 that is provided on opposite sides of the exterior thereof with concave finger- grips 32. Distal of hub receiving socket 30, but separated a distance therefrom, is a pair o laterally extending, coplanar stabilization wings 34 through which suture ties 22 have been stitched to skin 20 of forearm 14. According to one aspect of the present invention, coupling and stabilization system 16 is comprised of two classes of materials having selected physical properties that are substantially different. Vascular access catheter 10 and catheter coupling hub 26 arc secured to each other interior of the other components of coupling and stabilization system 16 that are visible in Figure 2. Together vascular access catheter 10 and cathe. i coupling hub 26 comprise a catheter assembly 36. Catheter assembly 36 is comprised of a first class of biocompatible materials that is appropriate for the conditions to which the implanted portion of vascular access catheter 10 is exposed in the cardiovascular system or in the tissues of a patient. The first class of materials must, in addition, be suited to the environment in which the extracorporeal portion of implanted vascular access catheter 10 is disposed and utilized outside the body of the patient. Lumen 28 should thus be enclosed in a conduit of relatively tough biocompatible material that extends from catheter coupling hub 26 through vascular access catheter 10 to the distal end thereof that is not visible in Figure 2, but that is disposed at a location in the vascular system of the patient at which repeated therapeutic activity is to be conducted.

Typically, catheter coupling hub 26 is a very rigid structure comprised of a much harder material than is catheter 10. Nonetheless, both of these components of catheter assembly 36 can be fabricated from polyurethane, provided that the hardness of each respective component is maintained within acceptable ranges through the use of differing types of polyurethane.

Catheter 10 should have a hardness in a range from about 74 Shore A durometer to about 65 Shore D durometer. Most preferably, the hardness of catheter 10 should be in a range from about 70 Shore A durometer to about 84 Shore D durometer. Most preferably, catheter 10 should have a hardness in a range from about 50 Shore A durometer to about 65 Shore D durometer. It is also acceptable within the scope of the teachings of the present invention to fabricate catheter 10 by coextruding an inner layer that is immediately adjacent to and defining of the lumen in catheter 10 with an outer layer on the exterior thereof that is comprised of a softer material than the inner layer

Coupling hub 26 should by comparison be generally much harder. For example, coupling hub 26 should have a hardness in a range in excess of 50 Shore D durometer More narrowiy, however, coupling hub 26 will perform adequately with a hardness in a range of from about 80 Shore D durometer to about 84 Shore D durometer Under appropriate circumstances, materials other than polyurethane can serve adequately as materials from which to fabricate either element of catheter assembly 36. Such alternative materials include polyvinylchloride, nylon, polyester, castable epoxy, and even metals, such as stainless steel or titanium.

Hub receiving socket 30, finger grips 32, and stabilization wings 34 are external features of an elastomeric stabilization sleeve 38 that encircles the distal end of catheter coupling hub 26 and a portion of vascular access catheter 10 distal thereof and adjacent thereto that are not visible in Figure 2. In contrast to catheter assembly 36, stabilization sleeve 38 is comprised of a second class of materials that is soft, flexible, and suitable for skin contacting applications. Currently, the material of choice for stabilization sleeve 38 is a thermoset material such as biocompatible silicone The hardness of stabilization sleeve 38 should be in a broad range of from about 35 Shore A durometer to about 100 Shore A durometer. More specifically, the hardness of stabilization sleeve 38 should be in a range of from about 74 Shore A durometer to about 80 Shore A durometer. The fabrication of sleeve 38 is not, however, limited to such materials, as the use of polyurethane possessed of appropriate hardness properties is also contemplated for use as stabilization sleeve 38. In any case, it is recommended that the material of which sleeve 38 is fabricated be a material that can be cleaned using a substance selected from the group comprising alcohol, acetone, and polyethylene glycol.

One of the selected physical properties that may advantageously be made to contrast between catheter assembly 36 and stabilization sleeve 38 is the visual appearance of each It is possible, for example, to use a single color of material for all sizes of catheter 10 used in a catheter assembly, such as catheter assembly 36. The material used for the corresponding stabilization sleeve 38 with each different size of catheter may, however, be rendered in a different hue in order to facilitate the ready identification according to a code of colors of the size of the catheter being utilized. The relationships among the components of coupling and stabilization system 16 are presented with enhanced clarity in Figure 3. There, catheter assembly 36. which is normally permanently secured to stabilization sleeve 38 at catheter coupling hub 2t>. nas with vascular access catheter 10 been withdrawn proximally from hub receiving socket 30, providing a disassembled perspective view of coupling and stabilization system 16. It is apparent, as a result, that catheter coupling hub 26 is an elongated structure that is secured at the distal end 40 thereof to the proximal end 42 of vascular access catheter 10 In actuality, cath-ter coupling hub 26 includes a pair of components These are a catheter receiving stent 44 and a coupling hub body 46. Catheter receiving stent 44 surrounds and is attached to the outer surface of the terminus of proximal end 42 of vascular access catheter 10. Coupling hub body 46 is attached at the distal end 48 thereof to the outer surface 49 of receiving stent 44 These interconnections can be effected either with an adhesive or, if all constituents of catheter assembly 36 are thermoplastic materials, by heat- induced welding

The proximal end 50 of coupling hub body 46 carries Luer connector threads 24 that encircle the proximal end 52 of lumen 28

Figure 3 also reveals that the portions of catheter assembly 36 not otherwise visible in the assembled state of coupling and stabilization system 16 illustrated in Figures 1 and 2 are in the assembled state of coupling and stabilization 16 encircled by stabilization sleeve 38. According to one aspect of the present invention, stabilization sleeve 38 is an elongated tube that has a distal end 54, a proximal end 56, and a passageway 58 extending longitudinally therebetween. Passageway 58 is so sized as to slideably receive catheter 10, but the minimum diameter of passageway 58 is less than the maximum outer diameter of catheter coupling hub 26. The inner diameter of passageway 58 in stabilization sleeve 38 at proximal end 56 thereof corresponds generally in size to the exterior of proximal end 50 of coupling hub body 46. A generally cylindrical hollow 59 is formed within hub receiving socket 30 capable of enclosing the full length of catheter assembly 36 other than the portion thereof that carries Luer connector threads 24. As a result, in the assembled state of coupling and stabilization system 16, distal end 48 of coupling hub body 46 abuts a portion of the interior of stabilization sleeve 38, while vascular access catheter 10 having a much smaller diameter than the outer diameter of coupling hub body 46 is slideably disposed in the balance of passageway 58 in stabilization sleeve 38. Other features of the exterior of stabilization sleeve 38 should receive mention relative to Figure 3.

Each of stabilization wings 34 can be seen to comprise a planar structure that extends laterally from opposite sides of stabilization sleeve 38 at an attachment location 60 While the configuration of stabilization wings 34 will be explored in greater detail subsequently, it can be observed that a suture recess 62 is formed in upper surface 64 of each of stabilization wings 34. At suture recess 62, the thickness of stabilization wings 34 is a minimum, thereby to facilitate, if desired, the stitching of coupling and stabilization system 16 to the skin of the patient using suture ties 22 in the manner shown in Figures 1 and 2. As attachment location 60 is distanced longitudinally along stabilization sleeve 38 from hub receiving socket 3,0, a strain relief region 66 is formed in stabilization sleeve 38 intermediate attachment location 60 and hub receiving socket 30 Strain relief region oό of stabilization sleeve 38 has in various embodiments thereof a length greater than 0.32 inches. In other embodiments, however, the length of strain relief region 66 has been greater than only 0.20 inches and at the very least greater than 0. 12 inches. A fmstocoiiical strain relief nose 68 is located on stabilization sleeve 38 distal of attachment location 60 The interior structure of stabilization sleeve 38 is illustrated in cross section in Figure 4. There, each of strain relief nose 68, attachment location 60, strain relief region 66, and hub receiving socket 30 can be correlated with corresponding interior structures of stabilization sleeve 38 along the length of passageway 58. At proximal end 56 of stabilization sleeve 38, proximal entryway 70 of passageway 58 affords access to hollow 59 within hub receiving socket 30. Hollow 59 includes a generally large diameter cylindrical region 72 at proximal entryway 70, a smaller diameter cylindrical region 74 at the opposite distal end of hollow 59, and a frustoconical medial section 76 therebetween. A yet smaller diameter, two-stage distal portion 78 of passageway 58 extends from cylindrical region 74 of hollow 59 to the open distal end 54 of stabilization sleeve 38 at the apex of strain relief nose 68. Distal portion 78 of passageway 58 includes a larger bore section 80 that passes through attachment location 60 and strain relief region 66, as well as a small bore region 82 that extends through strain relief nose 68. Although small bore region 82 of distal portion 78 of passageway 58 has the smallest inner diameter of any component of passageway 58, the inner diameter of small bore region 82 is nonetheless sufficiently large to slideably house vascular access catheter 10 therein.

On the other hand, it is in hollow 59, and against the distal end wall 84 of cylindrical region 74 in particular, that receiving stent 44 of catheter coupling hub 26 abuttingly engages a structure in passageway 58 in the assembled condition of coupling and stabilization system 16. Significantly, according to one aspect of the present invention, stabilization sleeve 38 is affixed to catheter assembly 36 only at hollow 59 using, by way of example, a room temperature vulcanizing silicone rubber adhesive. The portion of catheter assembly 36 distal of hollow 59 is slideably disposed in distal portion 78 of passageway 58.

One aspect of the configuration of stabilization sleeve 38 is best addressed relative to the elevation cross section of stabilization sleeve 38 shown in Figure 5 There, at attachment location 60, the lower patient contact surfaces 86 of stabilization wings 34 can be seen. Proximal of attachment location 60, the exterior of stabilization sleeve 38 in the vicinity of hub receiving socket 30 is correspondingly formed into a generally planar skin contact surface 88 that is disposed in a coplanar relationship with patient contact surface 86 on the same side of stabilization sleeve 38 therewith. The orientation of the common plane defined by patient contact surface 86 and skin contact surface 88 is such that when patient contact surface 86 and skin contact surface 88 engage the skin S of a patient, longitudinal axis L₃₈ of stabilization sleeve 38 is elevated relative to that common plane at an elevation angle A. In so doing, it is intended according to teachings of the present invention that the elastomeric nature of the material from which stabilization sleeve 38 is comprised will permit strain relief nose 68 to be displaced upwardly in a direction shown in Figure 5 by arrow F, so that the exterior of strain relief nose 68 on the same side of stabilization sleeve 38 as patient contact surface 86 and skin contact surface 88 will become coplanar therewith, resting on skin S of the patient in the manner shown, for example in Figure 7, subsequently.

Figure 6 illustrates, the relationship between the exterior features of catheter assembly 36 and the interior walls of passageway 58. As illustrated there, receiving stent 44 encircles the exterior of vascular access catheter 10, while coupling hub body 46 is attached to the exterior of receiving stent 44. Together, these elements comprise catheter assembly 36. Lumen 28 extending longitudinally through catheter assembly 36 includes catheter lumen 90 of vascular access catheter 10 and enlarged proximal terminus 92 at proximal end 50 of coupling hub body 46.

The generalized structural elements of stabilization wings 34 are best investigated in relation to the depictions in Figure 6. There, each of stabilization wings 34 can be seen to comprise an anchor root 96 that is secured directly to at attachment location 60. The width of anchor root 96 is the extent of anchor root 96 measured parallel to longitudinal access L₃₈ of stabilization sleeve 38. An anchor wing 98 is secured to the end of anchoi root 96 remote from stabilization sleeve 38. The width of anchor wing 98 is aiso measured parallel to longitudinal axis L₃₈ of stabilization sleeve 38. Anchor wing 98 is bounded by a trailing edge 100 oriented. toward hub receiving socket 30, a leading edge 102 on the opposite side of anchor wing 98 from trailing edge 100, and a tip 104 extending between leading edge 100 and trailing edge 102 remote from stabilization sleeve 38 In the embodiment of stabilizatiomwing 34 illustrated in Figure 6, trailing edge 100 and tip 104 are slightly convex, while leading edge 102 is linear and oriented at an acute angle to longitudinal axis L₁₈ of stabilization sleeve 38 proximal of attachment location 60. A strain relief region extension notch 106 is formed in trailing edge 100 of stabilization wing 34. thus causing the width of anchor root 96 to be less than the width of anchor wing 98 Figure 7 illustrates many of the same structures already discussed in relation to Figure 6. On the left side of Figure 7, however, enabled by the resiliency thereof, strain relief nose 68 has been displaced in a direction illustrated by arrow F, so that the exterior of strain relief nose 68 on the same side of stabilization sleeve 38 as patient contact surface 86 and skin contactasurface 88 rests in a coplanar relationship therewith on the skin S of a patient. While catheter coupling hub 26 is fixedly engaged within hub receiving socket 30 of stabilization sleeve 38, catheter 10 distal of and adjacent to catheter coupling hub 26 extends slideably through distal portion 78 of passageway 58. As a result, catheter 10 at strain relief nose 68 is not displaced in the direction of arrow F or to any similar degree as strain relief nose 68. Catheter 10 comes to be disposed within small bore region 82 and large bore region 88 of distal portion 78 of passageway 58 in a nonconcentric relationship. The flexibility of the material of which stabilization sleeve 38 is comprised in combination with the slidable disposition of vascular access catheter 10 within distal portion 78 of passageway 58 in stabilization sleeve 38 permits strain relief nose 68 and. to an extent, attachment location 60 to afford relief to catheter 10 from lateral types of bending strain.

As a result of the configuration of the portion of stabilization sleeve 38 proximal of attachment location 60, the longitudinal axis L₃₈ of stabilization sleeve 38 and the longitudinal axis of lumen 28 at the proximal end of catheter assembly 36 are disposed at an inclination angle A to the skin S of the patient.

According to one aspect of the present invention, in a catheter coupling and stabilization system, such as coupling and stabilization system 16, cooperating alignment means are provided for facilitating and stabilizing a predetermined rotational relationship between a stabilization sleeve of that system and the catheter coupling hub of the catheter assembly associated therewith. By way of example and not limitation, as illustrated to best advantage in Figure 8, the. exterior of catheter coupling hub 26 is provided with an upstanding, longitudinally extending alignment rib 110 that is received in correspondingly longitudinally aligned alignment rib receiving slot 112 formed in the wall of passageway 58 at cylindrical region 72 of hollow 59. Together, alignment rib 1 10 and alignment rib receiving slot 112 function as a key and keyway system 114. Figures 9A-9C depict the effects on the relationship of structures in the interior of coupling and stabilization system 16 resulting when stabilization wings 34 are secured to the skin of a patient and movement is imparted to catheter coupling hub 26.

Figure 9 A is an enlarged detail of a portion of coupling and stabilization system 1 illustrated in Figure 6. Sa tary effects of specific aspects of coupling and stabilization system 16 will be explored. Stabilization sleeve 38 is comprised of an elastomeric material. Catheter 10 is slideably disposed in distal portion 78 of passageway 58 in stabilization sleeve 38. Receiving stent 44 is permanently secured in hub receiving socket 30. Strain relief region 66 is located to advantage between attachment location 60 and the distal portion of catheter coupling hub 26.

In Figure 9B, a force has been applied to hub receiving socket 30 that has displaced hub receiving socket 30 and receiving stent 44 therein downwardly from the original position thereof indicated in phantom in a direction indicated by arrow R. The ability to freely pivot hub receiving socket 30 in this manner contributes to the ease with which extracorporeal tubing and medical equipment can be engaged to the proximal end of a catheter incorporating a coupling and stabilization system according to the present invention. The strain of this type of displacement of hub receiving socket 30 is not. however, communicated directly to the skin S of the patient at stabilization wings 34

Instead, strain relief region 66 assumes a twisted configuration 66 A. and vascular access catheter 10 is drawn along distal portion 78 of passageway 58 in the direction indicated by arrow X. The movement of hub receiving socket 30 as indicated by arrow R does not produce corresponding movement in stabilization wings 34 or in the skin of the patient to which stabilization wings 34 are attached Furthermore, upon the release oi whatever force produced the movement of hub receiving socket 30 indicated by arrow R the resiliency of strain relief. region 66 will restore hub receiving socket 30 to the original position thereof indicated in phantom in Figure 9B. Catheter 10 will correspondingly return longitudinally in a direction opposite that indicated by arrow X and resume ?he original position thereof, both in and out of the vascular system

Similar benefits occur in relation to lateral displacements of hub receiving socket 30 with receiving stent 44 fixed therein. Such a situation is illustrated in Figure 9C Theie. a force applied to hub receiving socket 30 has displaced hub receiving socket 30 in the direction indicated by arrow L. Instead of correspondingly displacing stabilization wings 34 or the skin of the patient to which stabilization wings 34 are attached, strain relief region 66 becomes distended into an elongated shape 66B, and vascular access catheter 10 slides freely within distal portion 78 of passageway 58. The strain imposed on hub receiving socket 30 is in effect dissipated or attenuated by strain relief region 66 of stabilization sleeve 38.

Strain relief region 66 affords other advantages as will be discussed in relation to Figures 10A-10D. These figures illustrate steps in the securement of the extracorporeal portion of a catheter embodying teachings of the present invention to the skin of a patient using medical adhesive tape 120 and coupling and stabilization system 16. The positioning of attachment location 60 for stabilization wings 34 at a distance from hub receiving socket 30 and thus catheter coupling hub 26 permits medical adhesive tape 120 to be used with optimum effectiveness.

Medical adhesive tape 120 has an adhesive side 122 that is shaded in the figures and a nonadhesive side 124 that is free of shading. In Figure ION the first step of this procedure is illustrated. Adhesive side 122 of medical adhesive tape 120 is disposed against the lower side of coupling and stabilization system 16 at strain relief region 66. The free ends 126. 128 of medical adhesive tape 120 extend laterally beyond tips 104 of stabilization sleeves 38, and trailing edges 104 of stabilization sleeves 38 overlie adhesive side 122 of medical adhesive tape 120. This latter situation is then altered in the manner illustrated in Figure 10B. Free ends 126, 128 of medical adhesive tape 120 are pivoted at strain relief region 66 about and over trailing e iges 100 of stabilization wings 34 Medical adhesive tape 120 thus continues unwrinkled to occupy strain relief region 66 between attachment location 60 and hub receiving socket 30. As illustrated in Figure 10C, free end 126 of medical adhesive tape 120 is next crossed over strain relief region 66 and the upper surface 62 of stabilization wing 34 on the opposite side of stabilization sleeve 38.

Finally, the same procedure is undertaken with relation to free end 128 of medical adhesive 120. The results are illustrated in Figure 10D. Through the use of medical adhesive tape 120 as a tie-down material, coupling and stabilization system 16 is fiimly secured at attachment location 60 to the skin of the patient. Still, substantial freedom of movement is permitted in hub receiving socket 30 and catheter coupling hub 26, as was discussed relative to Figures 9B and 9C. The length of strain relief region 66 contributes to this positive result, as does the slidable disposition of catheter 10 through the portion of stabilization sleeve 38 distal of catheter coupling hub 26.

Figures 1 1A-1 1C depict the effects on the relationship of structures in the interioi of coupling and stabilization .system 16 as a result of other types of movements imparted to catheter coupling hub 26 when stabilization wings 34 are secured to the skin of a patient as, for example, in the manner taught in Figures 10A-10D.

Figure 1 1 A is an enlarged detail of a portion of coupling and stabilization s stem 16 illustrated in Figure 7. In Figure 1 IB, a force has been applied to hub receiving socket 30 that has displaced hub receiving socket 30 and receiving stent 44 upwardly in a direction indicated by arrow T from the original position thereof shown in Figure 1 1A and indicated in Figure 1 IB in phantom. The ability to freely pivot hub receiving socket 30 in this manner contributes to the ease with which extracorporeal tubing and medical equipment can be engaged to the proximal end of a catheter incorporating a coupling and stabilization systen. according to the present invention. The strain of this type of displacement of hub receiving socket 30 is not, however, communicated directly to the skin S of the patient at stabilization wings 34.

Instead, strain relief region 66 assumes a twisted configuration 66C, and vascular access catheter 10 is drawn along distal portion 78 of passageway 58 in the direction indicated by arrow J. The movement of hub receiving socket 30 as indicated by arrow T does not produce corresponding movements in stabilization wings 34 or in the skin of the patient to which stabilization wings 34 are attached. Furthermore, upon the release o⁺ whatever force produced the movement of hub receiving socket 30 indicated by arrow T, the resiliency of strain relief region 66 restores hub receiving socket 30 to the original position thereof indicated in phantom in Figure 1 IB. Catheter 10 will correspondingly return longitudinally in the direction opposite that indicated by arrow J and resume the original position thereof, both in and out of the vascular system.

Similar benefits occur in relation to lateral displacement of hub receiving socket 30 with receiving stent 44 fixed therein. Such a situation is illustrated in Figure 1 1 C There, a force applied to hub receiving socket 30 has displaced hub receiving socket 10 in the direction indicated by arrow M. Instead of correspondingly displacing stabilization wings 34 or the skin of the patient to which stabilization wings 34 are attached, strain relief region 66 becomes distended into an elongated shape 66D, and vascular access catheter 10 slides freely within distal portion 78 of passageway 58. The strain imposed on hub receiving socket 30 is in effect dissipated or intenuated by strain relief region 66 ot stabilization sleeve 38.

Figures 12A-12D illustrate a number of alternative embodiments of catheter coupling and stabilization systems that incorporate teachings of the present invention and exhibit a variety of configurations of the stabilization sleeves utilized with such systems. In Figure 12A, a stabilization sleeve 38 A is illustrated. A pair of stabilization wings 140 projects laterally from opposite sides of stabilization sleeve 38 A at attachment location 60. Stabilization wing 140 has an anchor root 142 and an anchor wing 144 Trailing edge 146 of stabilization wing 140 is substantially linear and is oriented at an acute angle to the longitudinal axis of stabilization sleeve 38 A proximal of attachment location 60. Leading edge 148 of stabilization wing 140 is substantially straight adjacent to stabilization sleeve 38 A, but curves broadly at the end thereof remote from stabilization sleeve 38A to tangentially intersect tip 104 of stabilization wing 140. Tip 104, which is substantial' , linear, is disposed in a substantially parallel arrangement with the longitudinal axis of stabilization sleeve 38 A. A notch 152 in trailing edge 146 of stabilization wing 140 results in root 142 of stabilization wing 140 being narrower than anchor wing 144. In Figure 12B, yet another stabilization sleeve 38B is illustrated. A pair of stabilization wings 154 projects laterally from opposite sides of stabilization sleeve 38B at attachment location 60 Stabilization wing 154 is comprised of an anchor root 156 and an anchor wing 158. Trailing edge 160 of stabilization sleeve 154 is substantially linear, but is oriented at an acute angle to the longitudinal axis of stabilization sleeve 38B distal of attachment location 60. Leading edge 162 of stabilization sleeve 154 is concave and oriented generally at an acute angle to the longitudinal axis of stabilization sleeve 38B proximal of attachment location 60. Tip 164 of stabilization sleeve 154 is lineai and disposed at an acute angle with the longitudinal axis of stabilization sleeve 38B proximal of attachment location 60. A notch 166 is formed in trailing edge 160 of stabilization wing 154 adjacent to stabilization sleeve 38B.

In Figure 12C, a stabilization sleeve 38C is illustrated. A pair of stabilization wings 170 project laterally from opposite sides of stabilization sleeve 38C at attachment location 60. Stabilization wing 170 includes an anchor root 172 and an anchor wing 174. Both trailing edge 176 and leading edge 178 of stabilization wing 170 are substantially linear and are oriented perpendicular to the longitudinal axis of stabilization sleeve 38C Accordingly, trailing edge 176 and leading edge 178 are parallel, and anchor root 172 has a width that is equal to the -width of anchor wing 174. Tip 180 of stabilization wing 170 is substantially linear and is oriented substantially parallel to the longitudinal axis of stabilization sleeve 38C.

In Figure 12D, a stabilization sleeve 38D is illustrated. A pair of stabilization wings 182 projects laterally from opposite sides of stabilization sleeve 38D at attachment location 60. Each of stabilization wings 182 includes an anchor root 184 and an anchor wing 186. Both of trailing edge 188 and leading edge 190 of stabilization wing 182 are substantially linear and oriented at an acute angle to the longitudinal axis of stabilization sleeve 38D. Tip 1 2 of stabilization sleeve 182 is convex. Due to the relative orientation of each of trailing edge 188 and leading edge 190, however, the width of anchor root 184 is actually greater than the width of any portion of anchor wing 186.

The invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive The scope of the invention is, theiefoie. indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

What is claimed is:

1. An implantable vascular access catheter comprising: a. a conduit of relatively tough biocompatible material enclosing a longitudinally extending fluid flow lumen, said conduit having a proximal end configured for disposition in the vascular system of a patient and a distal end configured as a catheter coupling hub by which to effect mechanical and fluid interaction with extracorporeal medical equipment; b. an elastomeric sleeve suitable for skin contact applications encircling the distal end of said catheter coupling hub and a portion of said conduit distal of and adjacent thereto; and c attachment means for securing said sleeve at a predetermined position and in a predetermined orientation to the skin of a patient, said attachment means being located on the exterior of said sleeve at an attachment location proximal of said distal end of said catheter coupling hub, when said distal end of said catheter coupling hub is encircled by said sleeve.

2 A catheter as recited in Claim 1, wherein said sleeve is attached to said conduit exclusively at said catheter coupling hub

3. A catheter as recited in Claim 1 , wherein said portion of said conduit dista. of and adjacent to said catheter coupling hub extends slideably through said sleeve 4 A catheter as recited in Claim 1, wherein said sleeve comprises resilient means for reducing motion imparted to the skin of the patient by said attachment means due to motion imparted to said catheter coupling hub, said resilient means being located between said attachment means and said catheter coupling hub, when said distal end of said catheter coupling hub is encircled by said sleeve. 5. A catheter as recited in Claim 4, wherein said resilient means further functions for reducing all practical strain imposed on said conduit due to motion imparted to said catheter coupling hub

6 A catheter as recited in Claim 4, wherein said resilient means further functions for restoring said conduit to an original position thereof following displacement of said conduit therefrom due to motion imparted to said catheter coupling hub.

7. A catheter as recited in Claim 1, wherein the hardness of said catheter coupling hub is greater than the hardness of the portion of said conduit distal of said catheter coupling hub.

8. A catheter as recited in Claim 1 , wherein the hardness of said catheter coupling hub is in a range greater than or equal to approximately 50 Shore D durometer

9. A catheter as recited in Claim 8, wherein said hardness of said catheter coupling hub is in a range from about 80 Shore D durometer to about 84 Shore D durometer.

10. A catheter as recited in Claim 1, wherein the portion of said conduit distal of said catheter coupling hub has a hardness in a range from about 50 Shore A durometer to about 65 Shore D durometer.

1 1 A catheter as recited in Claim 10, wherein said hardness of said portion of said conduit distal of said catheter coupling hub is in a range of from about 72 Shore A durometer to about 100 Shore A durometer 12 A catheter as recited in Claim 1 1, wherein said hardness of said portion of said conduit distal of said catheter coupling hub is about 93 Shore A durometer

13. A catheter as recited in Claim 1, wherein the portion of said conduit distal of said cathet • coupling hub comprises: a. an inner layer immediately adjacent to and defining of said lumen and comprised of a first biocompatible material; and b. an outer layer on the exterior of said conduit comprised of a second biocompatible material that is softer than said first biocompatible material

14. A catheter as recited in Claim 1, wherein said catheter coupling hub is comprised of polyurethane. 15. A catheter as recited in Claim 1, wherein said catheter coupling hub is comprised of polyvinylchloride.

16 A catheter as recited in Claim 1 , wherein said catheter coupling hub is comprised of nylon.

17. A catheter as recited in Claim 1, wherein said catheter coupling hub is comprised of polyester.

18. A catheter as recited in Claim 1, wherein said catheter coupling hub is comprised of a metal.

19. A catheter as recited in Claim 18, wherein said metal comprises stainless steel. 20. A catheter a&recited in Claim 18, wherein said metal comprises titanium.

21. A catheter as recited in Claim 1, wherein the hardness of said sleeve is in a range of from about 35 Shore A durometer to about 100 Shore A durometer.

22. A catheter as recited in Claim 21 , wherein said hardness of said sleeve is in a range of from about 74 Shore A durometer to about 80 Shore A durometer 23. A catheter as recited in Claim 1, wherein said sleeve is comprised of a material that can be cleaned using a substance selected from the group comprising alcohol, acetone, and polyethylene glycol.

24. A catheter as recited in Claim 1, wherein said sleeve comprises silicone

25. A catheter as recited in Claim 1, wherein said sleeve comprises polyurethane. 26. A catheter as recited in Claim 1 , wherein said attachment means comprises a pair of stabilization wings extending laterally from said sleeve at said attachment location. and said portion of said conduit distal of and adjacent to said catheter coupling hub extends slideably through said sleeve at said attachment location. 27. A catheter as recited in Claim 26, wherein' a said stabilization wings are generally coplanar. each of said stabilization wings having an upper surface and a lower patient contact surface on the opposite side of each of said stabilization wings therefrom; b. the exterior of said sleeve proximally of said attachment location is formed into a generally planar skin contact surface disposed on the same side of said sleeve as said patient contact surfaces of said stabilization wings; and c. said sleeve at and proximal of said wing attachment location is so configured that when said patient contact surfaces of said stabilization wings a d said skin contact surface of said sleeve engage the skin of a patient with said distal end of said catheter coupling hub encircled by said sleeve, the longitudinal axis of said conduit at said proximal end thereof is elevated at an angle to the skin of the patient

28. A catheter as recited in Claim 1, wherein said attachment means and said sleeve are integrally formed of a single material.

29 A catheter as recited in Claim 4, wherein said resilient means comprises a strain relief region through which said portion of said conduit distal of and adjacent to said catheter coupling hub slideably extends.

30. A catheter as recited in Claim 1. wherein said sleeve is colored, and the color of said sleeve is preselected to correspond to the size of the outer diameter of said conduit distal of said catheter coupling hub.

31. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising: a. a catheter assembly comprised of a first class of materials, said catheter assembly comprising: i. a catheter having a proximal end and a distal end; and ii. a catheter coupling hub secured at the distal end thereof to said proximal end of said catheter; and b. a stabilization sleeve having a passageway extending longitudinallv therethrough configured to slideably receive said catheter and to abut said distal end of said catheter coupling hub, said distal end of said catheter coupling hub being secured in the proximal end of said passageway, a portion of said proximal end of said catheter immediately adjacent said distal end of said catheter coupling hub extending therefrom slideably through said passageway to the distal end thereof, and said stabilization sleeve being comprised of a second class of materials having selected physical properties substantially different from corresponding selected physical properties of said first class of materials. 32. A system as recited in Claim 3 1, wherein said first class of materials comprises thermoplastic materials that are durable relative to conditions to which the implanted portion of a cardiovascular access catheter is exposed in the cardiυvasculai system or the tissues of a patient and relative to the environment in which the extracorporeal portion of an implanted catheter is disposed and utilized. 33. A system as recited in Claim 32, wherein said first class of materials comprises polyurethane materials.

34. A system as recited in Claim 33. wherein: a. said catheter is comprised of a first polyurethane material, and b. said catheter coupling hub is comprised of a second polyurethane material. 35. A system a$*ecited in Claim 34, wherein said first polyurethane material is softer than said second polyurethane material.

36. A system as recited in Claim 31 , wherein said first class of materials comprises castable epoxy materials.

37. A system as recited in Claim 31 wherein said second class of materials comprises soft, flexible materials suitable for skin contacting applications.

38. A system as recited in Claim 37, wherein said second class of materials comprises thermoset materials.

39. A system as recited in Claim 38, wherein said second class of materials comprises biocompatible silicone materials. 40. A system as recited in Claim 3 1, wherein: a said first class of materials comprises thermoplastic materials that are durable relative to conditions to which the implanted portion of a vascular access catheter is exposed in the cardiovascular system or the tissues of a patient and relative to the environment in which the extracorporeal portion of an implanted catheter is disposed and utilized; and b said second class of materials comprises soft, flexible materials suitable for skin contacting applications.

41 A system as-recited in Claim 40, wherein said second cla.ss of materials comprises thermoset materials. 42. A system as recited in Claim 41, wherein a. said first class of materials comprises polyurethane materials; and b said second class of materials comprises biocompatible silicone materials.

43 A system as recited in Claim 3 1 , wherein a. said first class of materials comprises polyurethane materials; and b said second class of materials comprises biocompatible silicone materials

44. A system as recited in Claim 43, wherein. a said catheter is comprised of a first polyurethane material; and b. said catheter coupling hub is comprised of a second polyurethane material. 45. A system assrecited in Claim 44, wherein said first polyurethane material is softer than said second polyurethane material

46. A system as recited in Claim 31, wherein said catheter coupling hub comprises: a. catheter receiving stent encircling and attached to the outer surface of the terminus of said proximal end of said catheter; and b. a hub body attached to the outer surface of said receiving stem, the outer diameter of said hub body being substantially larger than the outer diameter of said receiving stent.

47 A system as recited in Claim 46, wherein said terminus of said proximal end of said catheter is attached to said receiving stent using adhesive, and said receiving stent is attached to said hub body using adhesive.

48. A system as recited in Claim 46, wherein said first class of materials comprises thermoplastic materials that are durable relative to conditions to which the implanted portion of a vascular access catheter is exposed in the vascular system or the tissues of a patient and relative to the environment in which the extracorporeal portion of an implanted catheter is disposed and utilized

49. A system as recited in Claim 48. wherein said first class of materials comprises poly irethane materials.

50. A system as recited in Claim 49, wherein: a. said catheter is comprised of a first polyurethane material; b. said catheter coupling hub is comprised of a second polyurethane material, and c said receiving stent is comprised of a third polyurethane material

51 A system as recited in Claim 50, wherein said first polyurethane material is softer than said second polyurethane material or said third polyurethane material

52. A system as recited in Claim 31, wherein: a. said first class of materials comprises materials selected from a group including polyurethane materials and castable epoxy materials; and b said second class of materials comprises soft, flexible materials suitable for skin contacting applications.

53. A system as recited in Claim 31 , wherein: a. said first class of materials comprises hard polyurethane materials; and b said second class of materials comprises soft polyurethane materials. 54. A system as recited in Claim 53, wherein: a. said catheter is comprised of a first hard polyurethane material; and b. said catheter coupling hub is comprised of a second hard polyurethane material.

55. A system as recited in Claim 54, wherein said first hard polyurethane material is so ter than said second hard polyurethane material.

56 A system as recited in Claim 3 1, wherein said second class of materials is colored, and the color of said second class of materials is preselected to correspond to the size of the outer diameter of said catheter.

57. A system as recited in Claim 31, wherein said distal end of said catheter coupling hub is secured in said proximal end of said passageway with a room temperature vulcanizing silicone rubber adhesive.

58 A system as recited in Claim 31. wherein said stabilization sleeve comprises, a. a pair of coplanar anchor wings disposed on opposite sides of saiu stabilization sleeve generally parallel to the longitudinal axis thereof at an attachment location distal of said distal end of said catheter coupling hub, when said distal end of said catheter coupling hub is secured in said proximal end of said passageway, each of said anchor wings having a trailing edge oriented to ard the proximal end of said stabilization sleeve; and b a notch formed in said trailing edge of each of said anchor wings adjacent said stabilization sleeve.

59. A system as recited in Claim 58, wherein said attachment location is remote from said distal end of said catheter coupling hub, when said catheter coupling hub is secured in said proximal end of said passageway.

60 A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter- said system comprising. a. a cat eter assembly comprised of a first class of materials, said catheter assembly comprising: i. a catheter having a proximal end and a distal end; and ii. a catheter coupling hub secured at the distal end thereof to said proximal end of said catheter; and b a stabilization sleeve encircling said distal end of said cathetei coupling hub and a portion of said proximal end of said catheter immediately adjacent thereto, said stabilization sleeve being comprised of a second class of materials having selected physical properties substantially different from corresponding selected physical properties of said first class of materials, and said stabilization sleeve comprising: i an elongated tube having a proximal end, a distal end, and a passageway extending longitudinally therebetween sized to slideably receive said catheter, ii. a catheter coupling hub receiving socket at said proximal end of said tube, said distal end of said catheter coupling hub being secured in said hub receiving socket; iii. a pair of stabilization wings extending laterally from opposite sides of said tube at an attachment location thereon remote from said hub receiving socket; and iv a strain relief region positioned intermediate said attachment location and said hub receiving socket, said cathetet extending slideaoly through said passageway at said strain relief region and at said attachment location. 61. A system as recited in Claim 60, wherein said first class of mateuals comprises thermoplastic materials that are durable relative to conditions to which th implanted poraon of a vascular access catheter is exposed in the vascular system or the tissues of a patient and relative to the environment in which the extracorporeal portion of an implanted catheter is disposed and utilized.

62. A system as recited in Claim 61 , wherein said first class of materials comprises polyurethane materials. 63. A system assεecited in Claim 62, wherein: a. said catheter is comprised of a first polyurethane material; and b. said catheter coupling hub is comprised of a second polyurethane material.

64. A system as recited in Claim 63, wherein said first polyurethane material is softer than said second polyurethane material.

65. A system as. recited in Claim 60, wherein said first class of materials comprises materials chosen from a group including polyurethane materials and castable epoxy materials.

66. A system as recited in Claim 60, wherein said second class of materials comprises soft, flexible materials suitable for skin contacting applications.

67. A system as recited in Claim 66, wherein said second class of materials comprises thermoset materials.

68. A system as recited in Claim 67, wherein said second class of materials comprises biocompatible silicone materials. 69. A system as recited in Claim 60, wherein: a. said first class of materials comprises thermoplastic materials that are highly durable relative to conditions to which the implanted portion of a vascular access catheter is exposed in the vascular system or the tissues of a patient and relative to the environment in which the extracorporeal portion of an implanted catheter is disposed and utilized; and b. said second class of materials comprises soft, flexible materials suitable for skin contacting applications.

70. A system as.recited in Claim 69, wherein said second class of materials comprises thermoset materials. 71. A system as recited in Claim 70, wherein: a. said first class of materials comprises polyurethane materials, and b. said second class of materials comprises biocompatible silicone materials.

72. A system as recited in Claim 60, wherein: a. said first class of materials comprises polyurethane materials; and b. sai «§econd class of materials comprises biocompatible silicone materials.

73. A system as iecited in Claim 72, wherein: a. said catheter is comprised of a first polyurethane material; and b. said catheter coupling hub is comprised of a second polyurethane material.

74. A system as recited in Claim 73, wherein said first polyurethane material is softer than said second polyurethane material.

75 A system as recited in Claim 60, wherein said catheter coupling hub comprises: a. a catheter receiving stent encircling and attached to the outer surface of the terminus of said proximal end of said catheter; and b. a hub body attached to the outer surface of said receiving stent. the outer diameter of said hub body being substantially larger than the outer diameter of said receiving stent. 76. A system as recited in Claim 75, wherein said terminus of said proximal end of said catheter is attached to said receiving stent using adhesive, and said receiving stent is attached to said hub body using adhesive.

77. A system as recited in Claim 75, wherein said terminus of said proximal end of said catheter is welded to said receiving stent, and said receiving stent is welded to said hub body.

78. A system as recited in Claim 75, wherein said first class of materials comprises thermoplastic materials that are highly durable relative to conditions TO wnich the implanted portion of a vascular access catheter is exposed in the vascular svstem or the tissues of a patient and relative to the environment in which the extracorporeal portion f an implanted catheter is disposed and utilized.

79. A system as recited in Claim 77, wherein said first class of materials comprises polyurethane materials.

80. A system as recited in Claim 79, wherein: a. said catheter is comprised of a first polyurethane material; b. said catheter coupling hub is comprised of a second polyurethane material; and c. said-receiving stent is comprised of a third polyurethane material.

81. A system as recited in Claim 80, wherein said first polyurethane material is softer than said second polyurethane material or said third polyurethane material

82. A system as recited in Claim 60, wherein: a. said first class of materials comprises hard polyurethane materials; and b. said second class of materials comprises soft polyurethane materials.

83. A system as recited in Claim 82, wherein: a. said catheter is comprised of a first hard polyurethane material; and b. said catheter coupling hub is comprised of a second harα polyurethane material.

84 A system as recited in Claim 83, wherein said first hard jolyurethane material is softer than said second hard polyurethane material.

85. A system as recited in Claim 60, wherein the diameter of said passageway at said strain relief region is greater than the outside diameter of said catheter 86. A system as recited in Claim 60, wherein the length of said strain relief region is greater than 0.12 inches.

87. A system as recited in Claim 86, wherein the length of said strain relief region is greater than 0.20 inches.

88. A system as recited in Claim 87. wherein the length of said strain relief region is greater than 0.32 inches.

89. A system as recited in Claim 60, wherein the wall of said passageway at said hub receiving socket and the exterior of said catheter coupling hub are provided with cooperating alignment means for facilitating and stabilizing a predetermined rotational relationship between said stabilization sleeve and said catheter coupling hub. when said distal end of said catheter coupling hub is secured in said hub receiving socket

90. A system as recited in Claim 89, wherein said alignment means comprises: a. an elongated alignment rib upstanding on the exterior of said catheter coupling hub and oriented generally parallel to the longitudinal axis of said catheter assembly; and b. an alignment rib receiving slot formed in said wall of said passageway at said hub receiving socket oriented generally parallel to the longitudinal axis of said stabilization sleeve.

91. A system as recited in Claim 60, wherein radially opposed finger grips are provided on the exterior of said tube at said hub receiving socket. 92. A system as recited in Claim 60, wherein: a. each of said stabilization wings has an upper surface and a generally planar patient contact surface on the opposite side thereof from said upper surface; b. the exterior of said tube at said hub receiving socket is formed into a generally planar skin contact surface disposed on the same side of said tube as said patient contact surfaces of said stabilization wings; and c. said tube at said wing attachment location and at said hub receiving socket is so configured that when said patient contact surfaces of said stabilization wings and said skin contact surface of said hub receiving socket engage the skin of a patient with the distal end of the catheter coupling hub positioned in said hub receiving socket, the longitudinal axis of said catheter at said proximal end thereof is elevated at an angle to the skin of the patient.

93. A system as recited in Claim 60, further comprising a strain relief nose located distal of said wing attachment location.

94. A system as recited in Claim 93, wherein the diameter of said passageway at said strain relief nose is greater than or equal to the outer diameter of said catheter.

95. A system as recited in Claim 93, wherein the exterior of said strain relief nose is frustoc nical.

96. A system as uecited in Claim 60, wherein each of said stabilization wings is provided with a suture recess at which the thickness of each respective of said stabilization

97. A system as recited in Claim 60, wherein a strain relief region extension notch is formed in the edge of each of said stabilization wings adjacent to said strain relief region

98. A system as recited in Claim 97, wherein said edge of each of said stabilization wings adjacenfrto said strain relief region is oriented at an acute angle to the longitudinal axis of said tube proximal of said wing attachment location.

99. A system as recited in Claim 60, wherein said second class of materials is colored, and the color of said second class of materials is preselected to correspond to the size of the outer diameter of said catheter. 100. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, wherein said system comprises: a. a catheter having a proximal end and a distal end; b. a catheter coupling hub secured at the distal end thereof to said proximal end of said catheter; and c. a stabilization sleeve encircling said distal end of said catheter coupli •_> hub and a portion of said proximal end of said catheter immediatel) adjacent thereto, said stabilization sleeve comprising: i. an elongated tube having a proximal end. a distal end, and a passageway extending longitudinally therebetween sized to slideably receive said catheter; ii . a catheter coupling hub receiving socket at said proximal end of said tube with the distal end of said catheter coupling hub secured therein; iii. a pair of stabilization wings extending laterally from opposite sides of said tube at an attachment location thereon remote from said hub receiving socket; and iv a strain relief region positioned intermediate said attachment location and said hub receiving socket, said catheter extending slideably through said passageway at said strain relief region and at said attachment location

101 . A system as recited in Claim 100. wherein the diameter of said passageway at said strain relief region is greater than the outside diameter of said catheter

102. A system as recited in Claim 100, wherein the length of said strain relief region is greater than 0. 12 inches.

103 A system as recited in Claim 102, wherein the length of said strain relief region is greater than 0.20 inches. 104. A system assrecited in Claim 103, wherein the length of said strain relief region is greater than 0.32 inches.

105. A system as recited in Claim 100, wherein the wall of said passageway at said hub receiving socket and the exterior of said catheter coupling hub are provided with cooperating alignment means for facilitating and stabilizing a predetermined rotational relationship between said stabilization sleeve and said catheter coupling hub when said distal end of said catheter coupling hub is positioned in said hub receiving socket

106. A system as recited in Claim 105 , wherein said cooperating alignment means comprise: a. an alignment rib upstanding on the exterior of said catheter coupling hub and oriented generally parallel to the longitudinal axis of said catheter assembly; and b an alignment rib receiving slot in said wall of said passagewav at said hub receiving socket oriented generally parallel to the longitudinal axis of said stabilization sleeve 107. A system as recited in Claim 100, wherein radially opposed finger grips are provided on the exterior of said tube at said hub receiving socket. 108. A system as recited in Claim 100, wherein: a. each of said stabilization wings has an upper surface and a generall> planar patient contact surface on the opposite side thereof from said upper surface, b. the exterior of said tube at said hub receiving socket is formed into a generally planar skin contact surface that is disposed on the same side of said tube as said patient contact surfaces of said stabilization wings; and c. said fj$be at said wing attachment location and at said hub receiving socket is so configured that when said patient contact surfaces of said .stabilization wings and said skin contact surface of said hub receiving socket engage the skin of a patient with said distal end of the catheter coupling hub secured in said hub

57 - receiving socket, the longitudinal axis of said catheter at said proximal end thereof is elevated at an angle to the skin of the patient.

109. A system as recited in Claim 100, further comprising a strain relief nose located distal of said wing attachment location. 1 10. A system as-cecited in Claim 109, wherein the diameter of said passageway at said strain relief nose is greater than or equal to the outer diameter of the catheter.

1 1 1. A system as recited in Claim 109, wherein the exterior of said tube at said strain relief nose is frustoconical.

112. A system as recited in Claim 100, wherein each of said stabilization wings is provided with a suture recess at which the thickness of each respective of said stabilization wings is a minimum.

113. A system as recited in Claim 100, wherein a strain relief region extension notch is formed adjacent said wing attachment location in the edge of each of said stabilization wings adjacent to said strain relief region. 1 14. A system as recited in Claim 1 13, wherein said edge of each of said stabilization wings adjacent to said strain relief region is oriented at an acute angle to the longitudinal axis of said tube proximal of said attachment location.

1 15. A system as recited in Claim 100, wherein each of said stabilization wings comprises: a. an anchor wing root secured directly to said tube at said attachment location; b. an anchor wing at the end of said wing root remote from aid tube, said anchor wing being disposed generally parallel to the longitudinal axis υi said tube, and said anchor wing having a trailing edge oriented toward said proximal end of said tube; and c. a notch formed in said trailing edge of said anchor wing adjacent said wing root.

1 16. A system as., recited in Claim 100, wherein said stabilization sleeve is comprised of medical grade silicone. 1 17. A system as recited in Claim 100, wherein said stabilization sleev e is colored, and the color of said stabilization sleeve is preselected to correspond to the size of the outer diameter of said catheter.

1 18. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising: a. a catheter assembly comprised of a first class of materials, said catheter assembly comprising: i. a catheter having a proximal end and a distal end; and ii. a catheter coupling hub secured at the distal end thereof to said proximal end of said catheter; and b. a stabilization sleeve encircling said distal end of said catheter coupling hub and a portion of said proximal end of said catheter immediateiy adjacent thereto, said stabilization sleeve being composed of a second class of materials having selected physical properties substantially different from corresponding selected physical properties of said first class of materials, and said stabilization sleeve comprising: i. an elongated tube having a proximal end, a distal end, and a passageway extending longitudinally therebetween sized to slideably receive the catheter, the minimum diameter of said passageway being less than the maximum outer diameter of said catheter coupling hub; and ii. a pair of stabilization wings extending laterally from opposite sides of said tube at an attachment location thereon remote from said proximal end of said tube, said catheter extending slideably through said passageway at said attachment location.

1 19 A system as recited in Claim 118, further comprising a catheter coupling hub receiving socket at said proximal end of said tube configured to accept said distal end of said catheter coupling hub, said passageway at said hub receiving socket having a diameter substantially equal to the outside diameter of said catheter coupling hub

120 A system as recited in Claim 1 19, wherein each of said stabilization wing; comprises: a. an anchor wing root secured directly to said tube at said attachment location, said wing root having a width measured parallel to the longitudinal axis of said tube; and b. an anchor wing at the end of said wing root remote from said tube, said anchor wing beaiig disposed generally parallel to said longitudinal axis of said tube, and said anchor wing having a width measured parallel to said longitudinal axis of said tube that is greater than said width of said wing root.

121. A system as recited in Claim 120, wherein said anchor wing has a trailing edge oriented toward said hub receiving socket and a leading edge on the opposite side thereof, said leading edge of said anchor wing at said wing root coinciding with an edge of said wing root.

122. A system as recited in Claim 121, wherein said leading edge of said anchor wing is disposed at an acute angle to the center line of said tube proximal of said attachment location. 123. A system as recited in Claim 121, wherein said anchor wing is provided with a suture recess at which the thickness of said anchor wing is a minimum. J 24. A system as recited in Claim 121 , further comprising a. a strain relief region positioned intermediate said attachment location and said hub receiving socket; and b. a strain relief region extension notch formed in said trailing edge of said anchor wing adjacent said wing root.

125. A system as recited in Claim 124, wherein said hub receiving socket is located proximal of said trailing edge of said anchor wings.

126. A system as recited in Claim 1 18, wherein each of said stabilization wings comprises: a. an anchor wing root secured directly to said tube at said attachment location, said wing root having a width measured parallel to the longitudinal axis of said tube that is less than the length of said tube; and b an anchor wing at the end of said wing root remote from said tube 127. A system as recited in Claim 1 18, wherein a portion of said tube extends distally of said attachment location.

128. A system as recited in Claim 127, wherein said portion of said tube extending distal of said attachment location has a frustoconical exterior.

129. A system as recited in Claim 1 18, wherein said tube extends proximally of said attachment location. 130. A system as-necited in Claim 129, wherein said tube extends proximally of said stabilization wings.

131. A system as recited in Claim 1 18, wherein each of said stabilization wings comprises: a. an anchor wing root secured directly to said tube at said attachment location; b. an anchor wing at the end of said wing root remote from said tube, said anchor wing being disposed generally parallel to the longitudinal axis of said tube, and said anchor wing having a trailing edge oriented toward said proximal end of said tube; and c. a notch formed in said trailing edge of said anchor wing adjacent said wing root.

132. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising: a. a catheter having a proximal end and a distal end; b. a catheter coupling hub secured at the distal end thereof to said proximal end of said catheter; and c a stabilization sleeve encircling said distal end of said catheter coupling hub and a portion of said proximal end of said catheter immediately adjacent thereto, said stabilization sleeve comprising: i. an elongated tube having a proximal end, a distal end, and a passageway extending longitudinally therebetween sized to slideably receive said catheter, the minimum diameter of said passageway oemg les>. than the maximum outer diameter of said catheter coupling hub; and ii. a pair of stabilization wings extending laterally from opposite sides of said tube at an attachment location thereon remote from said proximal end of said tube, said catheter extending slideably through said passageway at said attachment location.

133. A system as recited in Claim 132, further comprising a hub receiving socket at said proximal end of said tube configured to accept said distal end of said catheter coupling hub. said passageway at said hub receiving socket having a diameter substantially equal to the outside diameter of said catheter coupling hub 134. A system asicecited in Claim 132, wherein each of said stabilization wings comprises: a. an anchor wing root secured directly to said tube at said attachment location, said wing root having a width measured parallel to the longitudinal axis of said tube; and b an anchor wing at the end of said wing root remote fi om said tube, said anchor wing being disposed generally parallel to said longitudinal xis of said tube, and said anchor wing having a width measured parallel to said longitudinal axis of said tube that is greater than said width of said wing root.

135. A system as recited in Claim 134, wherein said anchor wing has a trailing edge oriented toward said proximal end of said tube of said stabilization sleeve and a leading edge on the opposite side thereof, said leading edge of said anchor win;.: at -wd wing root coinciding with an edge of said wing root

136. A system as recited in Claim 135, wherein said leading edge of said anchor wing is disposed at an acute angle to said longitudinal axis of said tube proximal of said attachment location.

137. A system as recited in Claim 135, further comprising. a. a strain relief region positioned intermediate said attachment location and said hub receiving socket; and b. a strain relief region extension notch formed in said trailing edge of said anchor wing adjacent said wing root.

138. A system as recited in Claim 135, wherein said hub receiving socket is located proximal of said trailing edge of said anchor wing.

139. A system as ecited in Claim 133, wherein each of said stabilization wings comprises: a an anchor wing root secured directly to said tube at said attachment location, said wing root having a width measured parallel to the longitudinal axis of said tube that is less than the length of said tube; and b. an anchor wing at the end of said wing root remote from said tube.

140. A system as recited in Claim 139, wherein a portion of said tube extends distally of said attachment location.

141 A system as recited in Claim 140, wherein said portion of said tube extending distal of said attachment location has a frustoconical exterior.

142. A system as recited in Claim 139, wherein said tube extends proximally of said attachment location.

143. A system as recited in Claim 142, wherein said tube extends proximally of said stabilization wings. 144. A system as recited in Claim 132, wherein each of said stabilization wings comprises: a. a planar anchor wing disposed generally parallel to the longitudinal axis of said stabilization sleeve at said attachment location, said anchor wing having a trailing edge oriented toward said proximal end of said tube of said stabilization sleeve; and b. a notch formed in said trailing edge of each of said anchor wings adjacent said stabilization sleeve.

145. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising: a. a catheter assembly comprised of a first class of materials, said catheter assembly comprising: i. a catheter having a proximal end and a distal end; and ii. a catheter coupling hub secured at the distal end thereof to said proximal end of said catheter; and b. a stabilization sleeve encircling said distal end of said catheter coupling hub and a portion of said proximal end of said catheter immediately- adjacent thereto, said stabilization sleeve being composed of a second class of materials having selected physical properties substantially different fiυrn corresponding selected physical properties of said first class of materials, and i< ό stabilization sleeve comprising: i. an elongated tube having a proximal end, a distal end. and a passageway extending longitudinally therebetween, said portion of said proximal end of said catheter immediately adjacent to said distal end of said catheter coupling hub extending therefrom slideably through said passageway to said distal end of said tube; ii. a pair of colored stabilization wings extending laterally from opposite sides of said tube at an attachment location thereon remote frorn said proximal end of said tube, said catheter extending slideably through said passageway at said wing attachment location; and iii . a catheter coupling hub receiving socket at said proximal end of said tube, said distal end of said catheter coupling hub being secured in said hub receiving socket.

146. A system as recited in Claim 145, wherein the color of said stabilization wings is preselected to correspond to the size of the outer diameter of said catheter.

147. A system as recited in Claim 145, wherein said tube is colored, and the color of said tube is preselected to correspond to the size of the outer diameter of said catheter 148. A system as recited in Claim 145, wherein said second class of materials is colored.

149 A system as recited in Claim 148, wherein the color of said second class of materials is preselected to correspond to the size of the outer diameter of said catheter.

150. A system as recited in Claim 145, wherein the minimum diameter of said passageway is less than the maximum outer diameter of said catheter coupling hub

151. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising: a. a catheter having a proximal end and a distal end, b. a catheter coupling hub secured a the distal end thereof to said proximal end of said catheter; and c a colored stabilization sleeve encircling said distal end of said catheter coupling hub and a portion of said proximal end of said catheter immediately adjacentfthereto, said stabilization sleeve comprising: i. an elongated tube having a proximal end. a distal end. and a passageway extending longitudinally therebetween, said portion of said proximal end of said catheter immediately adjacent to said distal end of said catheter coupling hub extending therefrom slideably through said passageway to said distal end of said tube; ii . a pair of stabilization wings extending laterally from opposite sides of said tube at an attachment location thereon remote from said proximal en-iof said tube, said catheter extending slideably through said passageway at said attachment location; and iii . a catheter coupling hub receiving socket at said proximal end of said tube with said distal end of said catheter coupling hub secured therein. 152. A system as recited in Claim 151. wherein the minimum diameter of said passageway is less than the maximum outer diameter of said catheter coupling hub

153. A system as recited in Claim 152, wherein the color of said stabilization sleeve is preselected to correspond to the size of the outer diameter of said catheter.

154. A system as recited in Claim 151, wherein said catheter and said cathetei coupling hub are comprised of thermoplastic materials that are durable relative to condition to which the implanted portion of a vascular access catheter is exposed in the vasculai system or the tissues of a patient and relative to the environment in which thπ extracorporeal portion of an implanted catheter is disposed and utilized.

155 A system as recited in Claim 151, wherein said stabilization sleeve is comprised of soft, flexible materials suitable for skin contacting applications

156. A system as recited in Claim 151, wherein said stabilization sleeve is comprised of biocompatible silicone materials.

157. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising: a. a catheter having a proximal end and a distal end; b a catheter receiving stent encircling and attached to the outer surface of the terminus of said proximal end of said catheter; c a catheter coupling hub body attached at the distal end thereof to the outer surface of said receiving stent, the outer diameter of said hub bυdv b ing substantially larger than the outer diameter of said receiving stent. d. an elongated tube having a proximal end, a distal end, and a passageway extending longitudinally therebetween sized to slideably receive said catheter; e. a hub body receiving socket at said proximal end of said tube with said distal end of said hub body secured therein; f a pair of stabilization wings extending laterally from opposite sides of said tube at an attachment location remote from said hub receiving socket, g. a strain relief region positioned along said tube intermediate said attachment location and said hub receiving socket: and h. a strain relief nose located on said tube distal of said attachment location, said catheter extending slideably through said passageway at said attachment location, at said strain relief region, and at said strain relief nose.

158. A system as recited in Claim 157, wherein said tube, said receiving socket, said stabilization wings, said strain relief region, and said strain relief nose are comprised of soft, flexible materials suitable for skin contacting applications.

159. A system as recited in Claim 158, wherein said materials suitable for skin contacting applications comprise biocompatible silicone materials.

160. A system as recited in Claim 157, wherein said tube, said receiving socket, said stabilization wings, said strain relief region, and said strain relief nose are colored, and the color of said tube, said receiving socket, said stabilization wings, said strain relie^f region, and said strain relief nose is a single color preselected to correspond to the size ol the outer diameter of said catheter.

161. A system as recited in Claim 157, wherein each of said stabilization wings comprises: a. an anchor wing root secured directly to said tube at said attachment location, said anchoring root having a width measured parallel to the longitudinal axis of said tube; and b an anchor wing at the end of said wing root remote from said tube, said anchor wing being disposed generally parallel to said longitudinal axis of said tube, and said anchor wing having a width measured parallel to aid longitudinal axis of said tube that is greater than said width of said wing root, said anchor wing comprising: i. a trailing edge oriented toward said receiving socket, ii. a leading edge on the opposite side of said anchor wing from said trailing e ge thereof, said leading edge of said anchor wing at said wing root coinciding with an edge of said wing root; and iii. a notch formed in said trailing edge of said anchor wing adjacent said wing root.

162 A system as recited in Claim 161, wherein said leading edge of said anchoi wing is disposed at an acute angle to said longitudinal axis of said tube proximal of said attachment location.

163 A system as recited in Claim 161, wherein said trailing edge of said anchor wing is disposed at an acute angle to said longitudinal axis of said tube proximal of said attachment lc .tion. 164. A catheter coupling and stabilization system for the extracorporeal portion of an implantable catheter, said system comprising. a a catheter having a proximal end and a distal end; b. a catheter coupling hub secured at the distal end thereof to said proximal end of said catheter; and c. a stabilization sleeve encircling said distal end of said catheter coupling hub and a portion of said proximal end of said catheter immediately adjacent thereto, said stabilization sleeve comprising: i. an elongated tube having a proximal end, a distal end, ana a passageway extending longitudinally therebetween sized to slideably receive said catheter, said distal end of said catheter coupling hub being secured in said passageway at said proximal end of said tube; and ii. attachment means for securing said tube at a predetermined position and in a predetermined orientation to the skin of a patient, said attachment means being located on the exterior of said tube at an attachment location proximal of said distal end of said catheter coupling hub, when said distal end of said catheter coupling hub is secured in said proximal end of said passageway.

165. A system as recited in Claim 1 4, wherein said attachment means comprises a pair of stabilization wings extending laterally from said tube at said attachment location, said catheter extending slideably through said tube at said attachment location.

166. A system as recited in Claim 165, wherein each of said stabilization wings comprises: a. an anchor wing root secured directly to said tube at said attachment location, said wing root having a width measured parallel to the longitudinal axis of said tube; and b. an anchor wing at the end of said wing root remote from said tube, said anchor wing being disposed generally parallel to said longitudinal axis of said tube, and said anchor wing having a width measured parallel to said longitudinal axis of said tube that is greater than said width of said wing root.

167. A system as recited in Claim 164, wherein said attachment means comprises a planar anchor wing extending laterally from said tube at said attachment location, said anchor wing being disposed generally parallel to the longitudinal axis of said tube, and said anchor wing having a leading edge oriented toward said distal end of said tube, a trailing edge oriented toward said proximal end of said tube, and a tip extending between -.α.f! leading edge and said trailing edge remote from said tube.

168. A system as recited in Claim 167, wherein: a. said anchor wing has a width measured parallel to said longitudinal axis of said tube; and b said anchor wing is secured to said tube by a wing root having a width measured parallel to said longitudinal axis of said tube that is less than said width of said anchor wing 169. A system as recited in Claim 167, wherein said leading edge is oriented generally perpendicular to said longitudinal axis of said tube at said attachment location

170. A system as recited in Claim 167, wherein said leading edge is oriented at ι. acute angle to said longitudinal axis of said tube proximal of said attachment location 171 A system as recited in Claim 167. wherein said leading edge is oriented at an acute angle to said longitudinal axis of said tube distal of said attachment location

172. A system as recited in Claim 167. wherein said leading edge is linear

173. A system as recited in Claim 167, wherein said leading edge is concave

174. A system as recited in Claim 167. wherein said leading edge is convex

175. A system as recited in Claim 167. wherein said trailing edge is oriented generally perpendicular to said longitudinal axis of said tube at said attachment location.

!76. A system as recited in Claim 167, wherein said trailing edge is oriented at an acute angle to said long wdinal axis of said tube proximal of said attachment location.

177. A system as recited in Claim 167, wherein said trailing edge is oriented at an acute angle to said longitudinal axis of said tube distal of said attachment location.

178. A system as recited in Claim 167, wherein said trailing edge is linear.

179. A system as recited in Claim 167, wherein said trailing edge is concave 180. A system as recited in Claim 167, wherein said tip is oriented generally parallel to said longitudinal axis of said tube at said attachment location.

181. A system as recited in Claim 167, wherein said tip is oriented at an acute angle to said longitudinal axis of said tube proximal of said attachment location.

182. A system as recited in Claim 167, wherein said tip is linear 183. A system as recited in Claim 167, wherein said tip is concave.

1 4 A system as recited in Claim 167, wherein said tip is convex

185. A catheter as recited in Claim 1. wherein said conduit encloses no mote than a single longitudinally extending fluid flow lumen.

186. A system as recited in Claim 31, wherein said catheter is a single lumen catheter.

187. A system as recited in Claim 1 18, wherein said second class of materials is colored, and the color of said second class of materials is preselected to correspond to the size of the ou.- r diameter of said catheter.